RightFit
RecruitingEarly Phase 1

Multiple Objective Particle Swarm Optimization Postural Instability Gait Disorder

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 89 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Using their MRI and CT, the investigators will construct patient-specific models of electrical current spread to neuroanatomical tar- gets surrounding the electrode."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests a computer method for choosing deep brain stimulation (DBS) settings to target specific brain pathways. It is for 60 people with Parkinson’s disease who have DBS on both sides of the brain in an area called the STN or GP. All settings will stay within the FDA-approved range for DBS for Parkinson’s disease.

Sixty patients will be enrolled in this study who are treated for Parkinson's disease (PD) with bilateral deep brain stimulation of subthalamic nucleus (STN) or globus pallidus (GP), who have a pre- operative 7 Tesla MRI including diffusion tensor imaging for tractography and a postoperative head CT for electrode localization, and in whom at least 3 months have passed since activation of their neurostimulators, for stabilization of clinical stimulator settings. Using their MRI and CT, the investigators will construct patient-specific models of electrical current spread to neuroanatomical tar- gets surrounding the electrode. Then applying nonlinear (particle swarm) optimization, patient- specific stimulator settings will be designed to maximally or minimally activate specific path- ways. In STN DBS: pedunculopallidal vs. pallidopeduncular pathways. In GP DBS: pallidopeduncular pathways at its origin in GP pars interna (GPi) vs. inhibitory afferents to GPi (from GP pars externa GPe). All stimulation falls within the the FDA-approved range for DBS for PD.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have Parkinson’s disease.
  • Have DBS on both sides of the brain.
  • Have a DBS system that can steer the electrical signal in different directions.
  • Had a strong MRI scan (at least 7 Tesla) before DBS surgery, with special images that map brain pathways.
  • Had a head CT scan after DBS surgery with image slices of at least 1 millimeter.
  • It has been at least 3 months since the DBS device was first turned on.

Who can't join

  • Have a nerve, brain, muscle, or bone condition that greatly affects walking, balance, or arm or leg movements.
  • Have dementia, a condition that affects memory and thinking.
  • Had prior brain surgery guided by precise coordinates, other than DBS for a movement disorder.
  • Are pregnant.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Diagnosis of PD * Bilateral DBS * Directional DBS electrode system * MRI, at least 7 Tesla, with diffusion tensor imaging, prior to DBS surgery * Head CT, at least 1mm cuts, following DBS surgery * At least 3 months since initial activation of the neurostimulator Exclusion Criteria: * Neurological or musculoskeletal disorder that significantly affects gait, balance, or limb movements * Dementia * Prior stereotactic neurosurgery other than DBS for movement disorder * Pregnancy

Study sites (1)

MN